CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and food and beverage industries. Our more than 1,600 employees provide best-in-class solutions that drive success and positive change for our clients, our people and our communities. CRB is a privately held company with a rich history of serving clients throughout the world, consistently striving for the highest standard of technical knowledge, creativity and execution.

CRB is looking for an energetic, self-motivated individual for the role of Director, CQV (Commissioning, Qualification and Validation). The Director, CQV is responsible for leading teams of CQV engineers and discipline SMEs, both internal and external, to plan, develop, execute, and manage CQV project lifecycle documents for new equipment, facilities, and processes in compliance with regulatory requirements and quality standards. The Director, CQV will lead the integration and delivery of CQV services on capital projects for our Life Sciences clients, as well as help clients navigate through regulatory requirements, devising and executing strategies that meets client timelines, and assessing / mitigating risk – all while driving leaner processes in order to achieve the end goal. This position requires a high level of organization, communication, leadership, and interpersonal skills that will be used to build strong relationships with internal and external clients.

Responsibilities

· Establish the CQV strategy with client’s Quality / Regulatory teams

· Oversee and develop the creation, revision and execution of Protocols, Reports, and Documents including, but not limited to: CQV Master Plan, Validation Project Plan, Utility and Facility PQs, Drawings, User requirement specifications, SOP’s, Automation Assessments, Impact Assessments Plans

· Develops and administers and/or assists CQV budget throughout the project.

· Develop, implement, and integrate (CQV) strategies aligned with internal standards, as well Client standards into design and construction plans.

· Develop execution schedule supporting Project Lifecycle (P6), with specific focus on developing detailed plans for all CQV phases which support the goals and overall timelines of the project, including Turnover. Ensure that any automation timelines and test requirements are proactively integrated into the overall equipment/system detailed schedule.

· Drive innovative ways to enhance integrated delivery (ONEsolutionTM) projects.

· Ensure that adequate staffing levels are applied (both internally and externally), within the costs constraints of the project to achieve the project goals. Escalate any resource constraints or conflicts proactively.

· Act as subject matter expert (SME) for CQV activities and in developing Project Execution Plans that meet regulatory requirements and industry standards

· Collaborate with cross-functional teams to identify and mitigate risks associated Integrated Project Delivery

· Develop and maintain relationships with key stakeholders for successful project execution.

· Conduct training sessions on CQV principles and best practices, identify opportunities for continuous improvement, and implement changes to optimize team integration of CQV processes.

· Write Scope of Work (SOW) proposals for new and prospective clients based on best practices of QRM (ICH 9,10,11), ISPE Baseline Guide 5, and ASTM E2500

· Responsible for ensuring all regulatory and GxP compliance items related to Validation are satisfied.

· Manage our partners and/or build a group to execute the integrated delivery strategy

· Future – assist in regulatory filings and agency reviews; operational training/staffing for clients

· Bachelor’s Degree in Life Sciences, Engineering, or Construction Management, or similar degree is required.

· 10+ years of Life Science experience in Commissioning, Qualification and Validation, including CSV (computer system validation), with experience in management of pharmaceutical projects. Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable

· Experience in beginning to end project delivery is highly preferred.

· Sound technical knowledge of both US and global regulatory requirements

· Good leadership skills to drive commissioning and qualification execution strategy in different, complex and dynamic projects.

· Flexible individual to manage and adapt to required situations to deliver the project on time and with the right quality to pass the health authorities inspections.

· Knowledge of ISPE guidelines with proven experience on projects. Proven experience in an EMA / FDA regulated environmental with good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.

· Exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S

· Excellent organizational, interpersonal, presentation, and communication skills

· Strongly motivated and well organized

· Comfortable working in a fast-paced and challenging environment

· Advanced knowledge and practical application of ACC, Kneat, Bluebeam and MS Office Suite (PowerPoint, Word and Excel, D365)

· Flexible and willing to travel as needed. Expectation of up to 50% travel depending on the type and location of client engagement.

All your information will be kept confidential according to EEO guidelines.

CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening.

CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails.

CRB offers a complete and competitive benefit package designed to meet individual and family needs.

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.